COVID-19 vaccine effectiveness among healthcare workers in Albania (COVE-AL): protocol for a prospective cohort study and cohort baseline data.
COVID-19 vaccine effectiveness among healthcare workers in Albania (COVE-AL): protocol for a prospective cohort study and cohort baseline data.
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DOI：
10.1136/bmjopen-2021-057741
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发表时间：
2022-03-23
期刊：
影响因子：
2.9
通讯作者：
Bino S
中科院分区：
文献类型：
--
作者：
Sridhar S;Fico A;Preza I;Hatibi I;Sulo J;Kissling E;Daja R;Ibrahim R;Lemos D;Rubin-Smith J;Schmid A;Vasili A;Valenciano M;Jorgensen P;Pebody R;Lafond KE;Katz MA;Bino S
在现实环境中，特别是在中等收入国家，COVID-19疫苗有效性仍然存在关键问题。我们描述了一项研究方案，以评估COVID-19 VE在阿尔巴尼亚（一个中高收入国家）预防卫生工作者（HWs）实验室确诊的SARS-CoV-2感染中的作用。在这项为期12个月的前瞻性队列研究中，我们招募了阿尔巴尼亚三家医院的医护人员。卫生工作者通过常规COVID-19疫苗运动接种疫苗。参与者完成了关于人口统计学、临床合并症和感染风险行为的基线调查。收集基线血清学样本并检测SARS-CoV-2刺突蛋白，收集呼吸道拭子并通过RT-PCR检测SARS-CoV-2。参与者每周完成症状问卷，并收集有症状的参与者的呼吸道拭子，对其进行SARS-CoV-2检测。在研究的第3、6、9和12个月，将收集血清学并检测针对SARS-CoV-2核衣壳蛋白和刺突蛋白的抗体。将使用分段比例风险模型（VE=1−HR）估计VE。从2021年2月到5月，招收了1504名HWs。中位年龄44岁（范围22-71岁），78%为女性。在入组时，72%的参与者SARS-CoV-2血清阳性。56%的参与者接种了一剂疫苗，其中98%的人在入组后4天内接种了第一针。所有卫生工作者均接种了辉瑞BNT162b2 mRNA COVID-19疫苗。研究方案和程序由世卫组织伦理审查委员会（参考编号CERC.0097A）和阿尔巴尼亚公共卫生研究所伦理审查委员会（参考编号156）审查和批准。所有参与者都提供了参与本研究的书面知情同意书。本研究的主要结果将在完成时发表在同行评议的期刊上。NCT04811391。
Critical questions remain about COVID-19 vaccine effectiveness (VE) in real-world settings, particularly in middle-income countries. We describe a study protocol to evaluate COVID-19 VE in preventing laboratory-confirmed SARS-CoV-2 infection in health workers (HWs) in Albania, an upper-middle-income country. In this 12-month prospective cohort study, we enrolled HWs at three hospitals in Albania. HWs are vaccinated through the routine COVID-19 vaccine campaign. Participants completed a baseline survey about demographics, clinical comorbidities, and infection risk behaviours. Baseline serology samples were also collected and tested against the SARS-CoV-2 spike protein, and respiratory swabs were collected and tested for SARS-CoV-2 by RT-PCR. Participants complete weekly symptom questionnaires and symptomatic participants have a respiratory swab collected, which is tested for SARS-CoV-2. At 3, 6, 9 months and 12 months of the study, serology will be collected and tested for antibodies against the SARS-CoV-2 nucleocapsid protein and spike protein. VE will be estimated using a piecewise proportional hazards model (VE=1−HR). From February to May 2021, 1504 HWs were enrolled. The median age was 44 (range: 22–71) and 78% were female. At enrolment, 72% of participants were seropositive for SARS-CoV-2. 56% of participants were vaccinated with one dose, of whom 98% received their first shot within 4 days of enrolment. All HWs received the Pfizer BNT162b2 mRNA COVID-19 vaccine. The study protocol and procedures were reviewed and approved by the WHO Ethical Review Board, reference number CERC.0097A, and the Albanian Institute of Public Health Ethical Review Board, reference number 156. All participants have provided written informed consent to participate in this study. The primary results of this study will be published in a peer-reviewed journal at the time of completion. NCT04811391.
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影响因子：
16.6
作者：
GeurtsvanKessel, Corine H.;Okba, Nisreen M. A.;Koopmans, Marion
通讯作者：
Koopmans, Marion
DOI：
10.1056/nejmoa2108891
发表时间：
2021-08-12
期刊：
The New England journal of medicine
影响因子：
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作者：
Lopez Bernal J;Andrews N;Gower C;Gallagher E;Simmons R;Thelwall S;Stowe J;Tessier E;Groves N;Dabrera G;Myers R;Campbell CNJ;Amirthalingam G;Edmunds M;Zambon M;Brown KE;Hopkins S;Chand M;Ramsay M
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DOI：
10.1056/nejmoa2107715
发表时间：
2021-09-02
期刊：
The New England journal of medicine
影响因子：
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作者：
Jara A;Undurraga EA;González C;Paredes F;Fontecilla T;Jara G;Pizarro A;Acevedo J;Leo K;Leon F;Sans C;Leighton P;Suárez P;García-Escorza H;Araos R
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Araos R
DOI：
10.1016/s0140-6736(21)00675-9
发表时间：
2021-04-17
期刊：
Lancet (London, England)
影响因子：
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作者：
Hall VJ;Foulkes S;Charlett A;Atti A;Monk EJM;Simmons R;Wellington E;Cole MJ;Saei A;Oguti B;Munro K;Wallace S;Kirwan PD;Shrotri M;Vusirikala A;Rokadiya S;Kall M;Zambon M;Ramsay M;Brooks T;Brown CS;Chand MA;Hopkins S;SIREN Study Group
通讯作者：
SIREN Study Group
影响因子：
4.5
作者：
Harris PA;Taylor R;Thielke R;Payne J;Gonzalez N;Conde JG
通讯作者：
Conde JG